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Effects of an Osteopathic Treatment Protocol on Sleep Quality

Primary Purpose

Sleep Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Osteopathic treatment protocol
Sham technique
Sponsored by
Ramón Mateos Alpuente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disorder focused on measuring Sleep quality, Heart Rate Variability, Stress, Osteopathic Manipulative Treatment, Manual Therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adults ranging from 18 to 80 years old and with a score greater than 5 on the Pittsburgh Sleep Quality Index

Exclusion Criteria:

  1. Recent head injuries or fractures.
  2. Having suffered a stroke or intracranial hemorrhage.
  3. Tumors.
  4. Epilepsy.
  5. Bradycardia.
  6. Hypotension.
  7. Heart disease
  8. Neurological problems
  9. Psychiatric problems

Sites / Locations

  • Ramón Mateos Fisioterapia y OsteopatíaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Intervention group

Control group

Arm Description

Group of patients that will receive the 4 techniques proposed to evaluate the changes on sleep quality

Group of patients that will receive a sham technique

Outcomes

Primary Outcome Measures

Sleep Quality
Sleep quality is measured using the Pittsburgh Sleep Quality Index before the intervention and one month after, having received three treatment sessions.

Secondary Outcome Measures

Heart Rate Variability
Changes in Heart Rate Variability (HRV) that will be measured and monitored before and at the end of the intervention using a portable HRV monitoring device (polar H10) that sends the signal to a computer for its collection and analysis through the Kubios HRV software
Perceived Stress
Assessment of perceived stress using the Cohen's Perceived Stress Scale (PSS), which will be completed before the first intervention and one week after completing the three planned interventions.

Full Information

First Posted
June 28, 2021
Last Updated
July 7, 2021
Sponsor
Ramón Mateos Alpuente
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1. Study Identification

Unique Protocol Identification Number
NCT04955392
Brief Title
Effects of an Osteopathic Treatment Protocol on Sleep Quality
Official Title
Effects of an Osteopathic Treatment Protocol on Sleep Quality
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
November 30, 2021 (Anticipated)
Study Completion Date
November 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ramón Mateos Alpuente

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
SIngle-centre interventional single-blinded randomized controlled trial, with random assignment of the subjects in two groups (intervention and control, 1: 1 ratio) and to be carried out with volunteers that present alterations in the quality of sleep. Eligible and accepting subjects participating in the study will be assigned to receive an osteopathic treatment protocol or a placebo technique
Detailed Description
Intervention protocol in the intervention group: The intervention protocol consists of 4 techniques that will be performed according to the following order: Inhibition of the suboccipital muscles. Parietal Lift. Sutherland Technique of Sphenobasilar Synchondrosis. Compression technique of the fourth ventricle (CV4). Intervention protocol in the control group: Placebo technique that consists of placing the hands on top of the skull without any therapeutic intention for five minutes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorder
Keywords
Sleep quality, Heart Rate Variability, Stress, Osteopathic Manipulative Treatment, Manual Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
SIngle-centre interventional single-blinded randomized contsubjectsrolled trial, with random assignment of the subjects in two groups (intervention and control, 1: 1 ratio)
Masking
ParticipantOutcomes Assessor
Masking Description
Eligible and recruited patients will be Randomized using OxMaR software (Oxford Minimization and Randomization).
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Group of patients that will receive the 4 techniques proposed to evaluate the changes on sleep quality
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Group of patients that will receive a sham technique
Intervention Type
Other
Intervention Name(s)
Osteopathic treatment protocol
Intervention Description
The intervention protocol consists of 4 techniques that will be performed according to the following order: Inhibition of the suboccipital muscles. Parietal Lift. Sutherland Technique of Sphenobasilar Synchondrosis. Compression technique of the fourth ventricle (CV4).
Intervention Type
Other
Intervention Name(s)
Sham technique
Intervention Description
Sham technique that consists of placing the hands on top of the skull without any therapeutic intention for five minutes.
Primary Outcome Measure Information:
Title
Sleep Quality
Description
Sleep quality is measured using the Pittsburgh Sleep Quality Index before the intervention and one month after, having received three treatment sessions.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Heart Rate Variability
Description
Changes in Heart Rate Variability (HRV) that will be measured and monitored before and at the end of the intervention using a portable HRV monitoring device (polar H10) that sends the signal to a computer for its collection and analysis through the Kubios HRV software
Time Frame
1 month
Title
Perceived Stress
Description
Assessment of perceived stress using the Cohen's Perceived Stress Scale (PSS), which will be completed before the first intervention and one week after completing the three planned interventions.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adults ranging from 18 to 80 years old and with a score greater than 5 on the Pittsburgh Sleep Quality Index Exclusion Criteria: Recent head injuries or fractures. Having suffered a stroke or intracranial hemorrhage. Tumors. Epilepsy. Bradycardia. Hypotension. Heart disease Neurological problems Psychiatric problems
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ramón Mateos Alpuente
Phone
+34 620768645
Email
info@ramonmateos.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramón Mateos Alpuente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ramón Mateos Fisioterapia y Osteopatía
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramón Mateos Alpuente
Phone
+34 620768645
Email
info@ramonmateos.es

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of an Osteopathic Treatment Protocol on Sleep Quality

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